Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44 mcg Administered Three Times Per Week by Subcutaneous Injection Compared With Copaxone® 20 mg Administered Daily by Subcutaneous Injection in the Treatment of Relapsing Remitting Multiple Sclerosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 764
- 试验地点
- 80
- 主要终点
- Time to First Relapse
研究概览
简要总结
The primary objective of the study is to assess the clinical efficacy of Rebif® 44 microgram (mcg) three times per week compared with Copaxone® 20 milligram (mg) daily in subjects with relapsing Multiple Sclerosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be between 18 and 60 years of age
- •Have definite relapsing multiple sclerosis
- •Have had one or more relapses within the prior 12 months
- •Must be in a clinically stable or improving neurological state during the four weeks prior to Study Day 1
- •Expanded Disability Status Scale (EDSS) score from 0 to 5.5, inclusive
- •If female, she must either be post-menopausal or surgically sterilized; or use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and be neither pregnant nor breast-feeding
- •Confirmation that the subject is not pregnant must be established by a negative serum human chorionic gonadotropin (hCG) pregnancy test within 7 days of Study Day 1 and a negative urine pregnancy test on Study Day
- •A pregnancy test is not required if the subject is post-menopausal or surgically sterilized
- •Be willing and able to comply with the protocol for the duration of the study
- •Voluntarily provide written informed consent and, for USA sites only, a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to their future medical care
排除标准
- •Have secondary progressive multiple sclerosis (SPMS) or primary progressive MS (PPMS)
- •Prior use of any interferon or glatiramer acetate
- •Have had treatment with oral or systemic corticosteroids or adrenocorticotrophic hormone (ACTH) within 4 weeks of Study Day 1 and within 7 days prior to the Day 1 magnetic resonance imaging (MRI)
- •Have a psychiatric disorder that is unstable or would preclude safe participation in the study.
- •Have significant leukopenia (white blood cell count < 0.5 times the lower limit of normal of the central laboratory) within 7 days of Study Day
- •Have elevated liver function tests (alanine aminotransferase [AST], aspartate aminotransferase [ALT], alkaline phosphatase > 2.0 times the upper limit of normal [ULN] of the central laboratory, or total bilirubin > 1.5 times the ULN of the central laboratory) within 7 days of Study Day 1 or a history of hepatitis (including infectious or drug-induced)
- •Prior cytokine or anti-cytokine therapy within 3 months prior to Study Day 1
- •Prior use of immunomodulatory or immunosuppressive therapy (including but not limited to cyclophosphamide, cyclosporin, methotrexate, azathioprine, linomide, mitoxantrone) within the 12 months prior to Study Day 1
- •Prior use of cladribine or have received total lymphoid irradiation
- •Have allergy or hypersensitivity to human serum albumin, mannitol, glatiramer acetate, natural or recombinant interferon-β, or any other components of the study drugs or gadolinium diethylenetriaminepentaacetic acid
- •Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to Study Day
- •Presence of systemic disease that might interfere with subject safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, human immunodeficiency virus [HIV], human T-cell lymphotrophic virus type I [HTLV-1])
- •Have had plasma exchange in 3 months prior to Study Day 1.
研究组 & 干预措施
Rebif®
干预措施: Rebif® (Drug)
Copaxone®
干预措施: Copaxone® (Drug)
结局指标
主要结局
Time to First Relapse
时间窗: Baseline up to 96 weeks
Relapse was defined as new, worsening or recurrent neurological symptoms attributed to multiple sclerosis that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. These new or worsening symptoms should be noted by subject and must be accompanied by at least 1 of the following: An increase of greater than or equal to (\>=) 1 grade in \>=2 functional scales of the Expanded Disability Status Scale (EDSS) or an increase of \>=2 grades in 1 functional scale of the EDSS or an increase of \>= 0.5 or an increase of \>=1.0 in EDSS if the previous EDSS was 0. Time to first relapse was defined as the time in days from the date of first dose of study treatment to the date of first multiple sclerosis relapse. The mean time to first relapse for the 25th percentile and the 30th percentile during the 96-week treatment period was measured by Kaplan-Meier estimates and was reported.
次要结局
未报告次要终点